Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
radiochemotherapy with 70 Gy
radiochemotherapy with 77 Gy
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring Local control
Eligibility Criteria
Inclusion Criteria:
- histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
- measurabel disease by CT and/or MRT and/or FDG-PET-CT
- fit for chemotherapy
- no prior radiotherapy or major surgery in the head/neck region
- Karnofsky Index > 60%
- informed consent
Exclusion Criteria:
- uncontrolled secondary cancer
- distant metastases
- pregnancy
- expected malcompliance
Sites / Locations
- Tuebingen university, radiation oncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard therapy
dose escalation
Arm Description
Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)
Standard plus 10% dose escalation to the hypoxic volume
Outcomes
Primary Outcome Measures
time to local recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT02352792
First Posted
January 28, 2015
Last Updated
January 30, 2015
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02352792
Brief Title
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Official Title
Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
Local control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)
Arm Title
dose escalation
Arm Type
Experimental
Arm Description
Standard plus 10% dose escalation to the hypoxic volume
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy with 70 Gy
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy with 77 Gy
Primary Outcome Measure Information:
Title
time to local recurrence
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
measurabel disease by CT and/or MRT and/or FDG-PET-CT
fit for chemotherapy
no prior radiotherapy or major surgery in the head/neck region
Karnofsky Index > 60%
informed consent
Exclusion Criteria:
uncontrolled secondary cancer
distant metastases
pregnancy
expected malcompliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Zips, Prof. Dr. med.
Phone
+49 7071 29 82141
Email
daniel.zips@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Theden, Mrs.
Phone
+49 7071 29 83420
Email
silke.theden@med-uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Welz, Dr. med.
Organizational Affiliation
radiation oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuebingen university, radiation oncology
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Welz, Dr. med.
Phone
+49 7071 29 86144
Email
stefan.welz@med.uni-tuebigen.de
12. IPD Sharing Statement
Learn more about this trial
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
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